Over the past twenty-five years, HIFU has been available primarily in Europe, Japan and England and to a lesser extent in other areas including but not limited to the Caribbean, Canada, South America, Australia, Russia and Ukraine. The HIFU process delivers a large amount of thermal energy to a confined space. This energy heats tissue to ablative levels while minimizing the effect on surrounding structures. Patients treated for prostate cancer with HIFU face significant adverse events that may also be present with other treatment modalities. A list of adverse events include primarily impotency, incontinence of urine, bowel injury, inability to kill all the cancer and urinary tract stricture or bladder neck contracture. The inability to validate a cure rate of better than 84% at greater than 5 years as well as a generalized recommendation to avoid the treatment of aggressive prostate cancer (arguably 35-40% of all prostate cancers) with HIFU invites a closer evaluation of the therapy and the protocol recommended by the manufacturer including all such therapies from EDAP™ (EDAP, International Corporation, Lyon, France), Sonacare™ (Focus Surgery, Indianapolis, Ind.) and Insightec™ (Taret Carmel, Israel) utilized heretofore in clinical practice or in research application.
At risk is the need to treat a patient a second time (using a reduced total energy measured in watts than the primary treatment), decreased ability to dissipate the energy due to a loss of tissue from the first treatment as well as compromised vascularity, a second anesthesia, loss of work time including a need to recuperate a second time, a potentially greater risk of adverse events (discussed below) as well as additional financial considerations involved in pre-operative costs, loss of business productivity and additional fixed costs for a second HIFU procedure including additional fees for all physicians involved as well as a technical component.